rifamycin enema / Cosmo Pharma - LARVOL DELTA

Cosmo Announces Positive Phase 2 Study of Rifamycin 1% Topically Acting Gel, Meeting the Primary Endpoint in Distal Ulcerative Colitis and Ulcerative Proctitis (Yahoo Finance) - "Phase 3 planning will be informed by FDA and EMA discussions...60 patients completed the study and comprised the primary analysis population (these were patients completing the study without major eligibility violations impacting the study results). 46.2% of patients treated with rifamycin 1% topically acting gel achieved clinical remission, compared with 14.3% in the placebo arm (a 3.2-fold increase), with the difference between the two arms reaching statistical significance (p = 0.0190)...Rifamycin 1% topically acting gel was well tolerated. Drug-related adverse events were low (8), and no unexpected safety findings emerged during the study...Analyses of secondary and exploratory endpoints are ongoing, and full results will be presented at upcoming major medical meetings or congresses."

New P3 trial • P2 data • Ulcerative Colitis